Petousis-Harris Helen, Jackson Catherine, Stewart Joanna, Coster Gregor, Turner Nikki, Goodyear-Smith Felicity, Lennon Diana
a General Practice & Primary Health Care; University of Auckland ; Auckland , New Zealand.
Hum Vaccin Immunother. 2015;11(7):1875-80. doi: 10.1080/21645515.2015.1016670.
Pain on vaccine injection and subsequent site reactions of pain and swelling may influence confidence in vaccines and their uptake. This study aimed to identify factors associated with reported pain on injection and reactogenicity following administration of a strain specific meningococcal B outer membrane vesicle vaccine. A retrospective analysis of data was conducted from a phase II single center randomized observer-blind study that evaluated the safety, reactogenicity and immunogenicity of this vaccine in 2 cohorts of healthy 8 to 12 y old children. Vaccine administration technique was observed by an unblinded team member and the vaccine administrator instructed on standardized administration. Participants kept a daily diary to record local reactions (erythema, induration and swelling) and pain for 7 d following receipt of the vaccine. Explanatory variables were cohort, vaccine, age, gender, ethnicity, body mass index, atopic history, history of frequent infections, history of drug reactions, pain on injection, vaccinator, school population socioeconomic status, serum bactericidal antibody titer against the vaccine strain NZ98/254, and total IgG. Univariate and multivariable analyses were conducted using ordinal logistic regression for factors relating to pain on injection and reactogenicity. Perceived pain on injection was related to vaccine formulation, vaccine administrator and ethnicity. Reactogenicity outcomes varied with ethnicity and vaccine administrator. Maintaining community and parental confidence in vaccine safety without drawing attention to differences between individuals and groups is likely to become increasingly difficult. Vaccine administration technique alone has the potential to significantly reduce pain experienced on injection and local vaccine reactions.
疫苗注射时的疼痛以及随后出现的疼痛和肿胀等局部反应可能会影响对疫苗的信心及其接种率。本研究旨在确定与接种特定菌株的B群脑膜炎球菌外膜囊泡疫苗后报告的注射疼痛和反应原性相关的因素。对一项II期单中心随机观察者盲法研究的数据进行了回顾性分析，该研究评估了该疫苗在两组8至12岁健康儿童中的安全性、反应原性和免疫原性。由未设盲的团队成员观察疫苗接种技术，并对疫苗接种者进行标准化接种指导。参与者在接种疫苗后连续7天每天记录局部反应（红斑、硬结和肿胀）和疼痛情况。解释变量包括队列、疫苗、年龄、性别、种族、体重指数、特应性病史、频繁感染史、药物反应史、注射时的疼痛、接种者、学校人群的社会经济地位、针对疫苗菌株NZ98/254的血清杀菌抗体滴度以及总IgG。使用有序逻辑回归对与注射疼痛和反应原性相关的因素进行单变量和多变量分析。注射时的感知疼痛与疫苗配方、疫苗接种者和种族有关。反应原性结果因种族和疫苗接种者而异。在不引起对个体和群体差异关注的情况下，维持社区和家长对疫苗安全性的信心可能会变得越来越困难。仅疫苗接种技术就有可能显著减轻注射时的疼痛和局部疫苗反应。
